Observation on clinical effects of herbal cake-partitioned moxibustion for knee osteoarthritis

Huang Zhen (黃振), Song Shuang-lin (宋雙臨)

Acupuncture Department of Hangzhou First People’s Hospital, Zhejiang 310006, China

Observation on clinical effects of herbal cake-partitioned moxibustion for knee osteoarthritis

Huang Zhen (黃振), Song Shuang-lin (宋雙臨)

Acupuncture Department of Hangzhou First People’s Hospital, Zhejiang 310006, China

Objective:To observe the clinical effects of herbal cake-partitioned moxibustion in the treatment of knee osteoarthritis (KOA).

Moxibustion Therapy; Indirect Moxibustion; Osteoarthritis, Knee; Patellofemoral Pain Syndrome

Knee osteoarthritis (KOA) is a common clinical degenerative osteoarthropathy, frequently seen in the middle-aged and old adults. It’s clinically manifested by pain, stiffness and dysfunction of the knee joint, seriously influencing the quality of life (QOL) and health of the patients. We treated 60 cases with herbal cake-partitioned moxibustion, in comparison with the therapeutic effects of 60 cases treated with oral administration of Diclofenac Sodium Sustained-release Tablets. Now, the report is given as follows.

1 Clinical Materials

1.1 Diagnostic criteria

In accordance with the diagnostic criteria for KOA in theGuiding Principles for Clinical Study of New Chinese Medicines[1]: repeated knee pain within the recent one month; narrowing space of the knee joint, subchondral bone sclerosis and/or cystic change, and osteophyte formation of the joint margin shown in X-ray imaging (standing or loading); clear and sticky joint fluid (at least twice); white blood count (WBC) ＜2 000/mL; middleaged and old patients (aged ≥ 40); morning stiffness≤30 min, and bone crepitus (sensation). KOA can be diagnosed when the former two items or the first, third,fifth and sixth items or the first, fourth, fifth and sixth items were satisfied.

1.2 Inclusion criteria

In conformity with the diagnostic criteria of KOA; with the age ranged from 40 to 70 years old; without administration of non-steroidal anti-inflammatory drugs and hormones for at least a month; in mild and moderate condition; and signed the informed consent. Those meeting the aforementioned criteria were recruited into the study.

1.3 Exclusion criteria

Not in conformity with the diagnostic criteria; with serious diseases in the cardiac, pulmonary, hepatic, renal and hematopoietic system, or complications influencing the knee joint (such as psoriasis, metabolic bone disease, acute trauma, etc.); women in pregnancy or lactation period; serious drug allergy; un-assessable effects due to un-stipulated treatment, or incomplete data impacting the assessment of the therapeutic effects; age below 40 or over 70 years old. Those were not be recruited into the study if there was one of the above situations.

1.4 Statistical method

The SPSS 12.0 version statistical software was used for statistical analysis. The measurement data were expressed by mean ± standard deviationwithttest. The enumeration data were processed by Chi square test.α＝0.05 was used as test standard.

1.5 General data

Totally, 120 cases with KOA were recruited from the Acupuncture Department of our hospital and were randomly divided by random digital table into an herbal cake-partitioned moxibustion (HCPM) group and a Western medicine (WM) group. The differences in gender, age and duration between the two groups were not statistically significant (allP＞0.05), indicating that the two groups were comparable (Table 1).

Table 1. Comparison of general data between the two groups

2 Therapeutic Methods

2.1 HCPM group

Herbal cake preparation:Cao Wu(Radix Aconiti Kusenzoffii),Wei Ling Xian(Radix Clematidis),Tou Gu Cao(Herba Speranskia Tuberculata),Ru Xiang(Olibanum),Mo Yao(Myrrha),Gong Ding Xiang(Flos Caryophylli), andChuan Xiong(Rhizoma Ligustici Chuanxiong), by equal portion, were ground into power and mixed with white vinegar into paste and then made into round herbal cake of 0.4 cm in thickness and 2.5 cm in diameter.

Moxa cone preparation: Moxa wool was modeled into conical moxa cone of 2 cm in diameter in the bottom and 2.5 cm in height (about 2 g).

Acupoints: Dubi (ST 35), Neixiyan (EX-LE 4), Liangqiu (ST 34), Xuehai (SP 10), Zusanli (ST 36), Yanglingquan (GB 34) and Yinlingquan (SP 9) on the affected side.

Methods: Each time, three acupoints were selected from the above acupoints. The herbal cakes were put on the acupoints and moxa cones were put on the herbal cakes for moxibustion (Figure 1). When the patient felt hot, moxa cones were replaced. Moxibustion was given till the skin became red but without causing blisters. Three cones were given to each acupoint for each session. The treatment was given once per day from Monday to Friday. Ten sessions made one course and the treatment was given continuously for two courses.

Figure 1. Herbal cake-partitioned moxibustion

2.2 WM group

Diclofenac Sodium Sustained-release Tablets (Voltaren, produced by Beijing Novartis Pharmaceuticals Co. Ltd., China, 75 mg/tablet), 75 mg each time, taken after meal, once per day. The therapeutic effects were observed after continuous administration for four weeks.

3 Observation of Therapeutic Effects

3.1 Observed measurements

Before and after treatment, Western Ontario and McMaster Universities Osteoarthritis index (WOMAC) was assessed. WOMAC has been acknowledged publicly the best evaluation scale for KOA, including three aspects of pain, morning stiffness and difficulty in daily activity, totally in 24 parameters, with the total score ranging from 0 point to 96 points (including 20 points of pain, 8 points of morning stiffness, and 68 points of daily activity). The higher the total score, the more serious the pathological situation[2].

3.2 Criteria of therapeutic effects

The total WOMAC scores of the patients were processed to calculate the index of the therapeutic effects in reference to Nimodipine method. Then, the therapeutic effects were assessed in accordance with the index of the therapeutic effects[3].

Index of therapeutic effects ＝ (Total WOMAC score before treatment － Total WOMAC score after treatment) ÷ Total WOMAC score before treatment × 100%.

Clinical cure: Index of therapeutic effects ≥80%.

Remarkable effect: Index of therapeutic effects≥50%, but ＜80%.

Effect: Index of therapeutic effects ≥25%, but＜50%.

Failure: Index of therapeutic effects ＜25%.

3.3 Results

3.3.1 Comparison of WOMAC scores before and after treatment between the two groups

The total WOMAC scores in the two groups were obviously lower than those of the same group before treatment, with statistically significant differences (bothP＜0.05), indicating that herbal cake-partitioned moxibustion and Western medication can improve the clinical symptoms of pain and morning stiffness of KOA patients. After treatment, the total WOMAC score was remarkably lower in the HCPM group than that in the WM group, with a statistically significant difference (P＜0.05), indicating that the clinical symptoms of pain and morning stiffness were alleviated remarkably in the HCPM group (Table 2).

Table 2. Comparison of WOMAC scores between the two groups

Table 2. Comparison of WOMAC scores between the two groups

Note: Compared with the same group before treatment, 1) P＜0.05; compared with the WM group, 2) P＜0.05

Group n Before treatment After treatment HCPM 60 63.15±8.13 28.63±4.561)2)WM 60 61.72±8.65 39.14±5.481)

3.3.2 Comparison of therapeutic effects between the two groups

The total effective rate was 86.7% in the HCPM group, remarkably higher than 73.3% in the WM group, with a statistically significant difference (P＜0.05), indicating that the clinical effect was better in the HCPM group (Table 3).

Table 3. Comparison of therapeutic effect between the two groups (case)

4 Discussion

KOA often results from complete destruction of the knee cartilage and lesion of the subchondral bone plate of the joint border[4]. An epidemiological survey has shown that the prevalence rate of KOA can account for 50% in people aged over 60, and 80% in people aged over 75, and the disability rate can reach as high as 53%[5]. Up to today, its pathogenesis is still unknown. Some scholars proposed the theory of cell factor[6-8], and theory of free radicals[9], etc. At present, there is no specific medication and method for KOA.

The therapeutic effect of acupuncture for KOA is affirmative[10-12]. Herbal cake-partitioned moxibustion is one of the commonly used moxibustion method and is a method of integrative application of herbal drugs and moxibustion, offering the triple effect of herbal drugs, moxibustion and acupoints. In the herbal cake,Cao Wu(Radix Aconiti Kusnezoffii) is spicy, hot and toxic in nature and can be used to search wind, remove dampness, disperse cold and stop pain.Wei Ling Xian(Radix Clematidis) is in migrating in nature and can be used to expel wind and dampness and dredge the meridians.Tou Gu Cao(Herba Speranskia Tuberculata) can be used to expel wind and dampness, activate blood, soothe the tendons and stop pain.Ru Xiang(Olibanum) andMo Yao(Myrrha) are used in combination as the important drugs to dredge Zang-fu organs and the meridians because of their strong fragrant and migrating nature, for activating blood, circulating qi, dredging the meridian and alleviating pain.Gong Ding Xiang(Flos Caryophylli) is spicy, warm and fragrant in nature and can be used to warm up the middle jiao, disperse cold, tonify the kidney and assist yang.Chuan Xiong(Rhizoma Ligustici Chuanxiong) can be used to activate blood, circulate qi, expel wind and stop pain. It has been proven by modern pharmacological study thatCao Wu(Radix Aconiti Kusenzoffii) contains aconitine and hypaconitine, and has the obvious analgesic, anti-inflammatory and anesthetic effects[13]. Dubi (ST 35), also termed Waixiyan, an acupoint from the Stomach Meridian, and Neixiyan (EX-LE 4) belongs to the important acupoints for problems of knee joint. Moxibustion at them can promote the actions of herbal drugs and moxibustion into the joint cavity and reach the diseased area. Liangqiu (ST 34), a Xi-Cleft acupoint of the StomachMeridian of Foot Yangming, has the effects to dredge the meridians, alleviate swelling and stop pain. Zusanli (ST 36), an important acupoint for strengthening the body, can be used to elevate the antioxidative and anti-fatigue ability by acupuncture[14]and to produce qi and blood, activate blood, dredge the collaterals, and strengthen the tendons and bones, for various paralytic problems of the lower limbs in particular[15].

It has been proven by the findings that HCPM and WM can remarkably alleviate pain, morning stiffness and daily activity of the patients. The total WOMAC score after treatment was obviously lower in the HCPM group than that in the WM group, and the total effective rate was remarkably higher in the HCPM group than that in the WM group, indicating that the herbal cake-partitioned moxibustion was remarkable effective, and it was better than oral administration of Diclofenac Sodium Sustained-release Tablets for KOA. During and after treatment, no obvious adverse reaction was seen, fully proving that the herbal cake-partitioned moxibustion was affirmative in the therapeutic effect for KOA and worthy of clinical application.

Conflict of Interest

The authors declared that there was no conflict of interest in this article.

Statement of Informed Consent

Informed consent was obtained from all individual participants included in this study.

Received: 20 January 2015/Accepted: 23 February 2015

[1] Ministry of Health of the People’s Republic of China. Guiding Principles for Clinical Study of New Chinese Medicines. Beijing: China Medical Science Press, 2002: 115-119.

[2] Stratford PW, Kennedy DM. Does parallel item content on WOMAC's pain and function subscales limit its ability to detect change in functional status? BMC Musculoskelet Disord, 2004, 5: 17.

[3] Roos EM, Kl?ssbo M, Lohmander LS. WOMAC osteoarthritis index. Reliability, validity, and responsiveness in patients with arthroscopically assessed osteoarthritis. Western Ontario and MacMaster Universities. Scand J Rheumatol, 1999, 28(4): 210-215.

[4] Lu ZY, Zhong NS. Internal Medicine. 7th Edition. Beijing: People’s Medical Publishing House, 2010: 903-907.

[5] Orthopedic Society of Chinese Medical Association. Diagnostic and therapeutic guidelines for osteoarthritis (2007). Zhongguo Yikan, 2007, 42(12): 30-32.

[6] Tan ZL, Xing GS, Li DD, Wang SY, Yu SL, Li SM, Zhang K, Wang Y. A study of the effects of cytokines on joint chondrocyte. Gu Yu Guanjie Sunshang Zazhi, 2003, 18(5): 316-318.

[7] He YH, Weng XS, Qiu GX. An investigation of the role played by IL-1β and TNF-α on the pathogenesis of osteoarthrosis of the knee. Chin J Orthop, 1999, 19(5): 281-284.

[8] Ren ZW, Yu YL, Jiang JY. Research progress of osteoarthritis-associated cellular factors. Guowai Yixue: Gukexue Fence, 2005, 26(4): 234-237.

[9] Xu P, Yao JF, Cai QK, Ji WZ, Sha HB. Analysis of the illness severity and the level of free radicals in patients with osteoarthritis. Orthop J Chin, 2001, 8(5): 469-471.

[10] Li JW, Xiang SY, Ma ZY, Feng YB, Tong HY, Geng HP, Ji J, Su X. Clinical observation on cake-separated mild-warm moxibustion for treatment of knee osteoarthritis. Zhongguo Zhen Jiu, 2008, 28(1): 17-19.

[11] Zhong ZL, Sun K, Cheng HL, Liu DC, Yang J. Observations on the therapeutic effect of herbal cake-separated moxibustion on knee osteoarthritis of blood stasis type. Shanghai Zhenjiu Zazhi, 2010, 29(1): 45-47.

[12] Zhou JF, Zhao JC, Li XW, Wang L, Yang Y. Warm needling moxibustion for knee osteoarthritis: a randomize controlled trial. J Acupunct Tuina Sci, 2014, 12(6): 346-349.

[13] Zhao YY, Cui XM, Dai Y, Wang CL, Miao H. Research progress of Cao Wu (Radix Aconiti Kusenzoffii). Techan Yanjiu, 2006, 1(1): 61-65.

[14] Liang Y, Fang JQ, Shao XM, Wang CX. Influence of transdermal electric stimulation of Zusanli (ST 36) on free radicals metabolism in rats with exhaustion from treadmill. Zhongguo Zhongyiyao Keji, 2008, 15(4): 251-252.

[15] Huang Z, Song SL. A brief talk on healthcare moxibustion of Zusanli (ST 36). Shandong Zhongyi Zazhi, 2009, 28(6): 373-374.

Translator:Huang Guo-qi (黃國琪)

隔藥餅灸治療膝骨性關節炎的療效觀察

目的：觀察隔藥餅灸治療膝骨性關節炎(knee osteoarthritis, KOA)的臨床療效。方法：將120例KOA患者按隨機數字表隨機分為2組, 每組60例。隔藥餅灸(herb cake-partitioned moxibusiton, HCPM)組給予隔藥餅灸治療，每日1次, 每星期治療5 d, 10次為1個療程。西藥(Western medicine, WM )組給予口服雙氯芬酸鈉緩釋片治療。治療前后采用西安大略與麥克馬斯特大學骨關節炎指數(Western Ontario and McMaster Universities osteoarthritis index, WOMAC)評分評介患者膝關節功能。兩組連續治療4星期后觀察臨床療效。結果：HCPM組總有效率為86.7%, WM組為73.3%, 兩組總有效率差異有統計學意義(P＜0.05)。治療后, 兩組WOMAC評分均與本組治療前有統計學差異(均P＜0.05), 兩組評分差異亦有統計學意義(P＜0.05)。結論：隔藥餅灸及口服雙氯芬酸鈉緩釋片均可以改善KOA患者的膝關節功能, 但隔藥餅灸療效優于口服雙氯芬酸鈉緩釋片。

灸法; 間接灸; 骨關節炎, 膝; 髕股疼痛綜合征

R245.8 【

】A

Author: Huang Zhen, master of medicine, associate chief physician of traditional Chinese medicine.

E-mail: cbk-81@163.com

Methods:A total of 120 cases with KOA were randomly divided into two groups by the random digital table, 60 cases in each group. The herbal cake-partitioned moxibustion (HCPM) group was treated by herbal cake-partitioned moxibustion, once per day and five days per week, with ten sessions as one course. The Western medication (WM) group was treated by the oral administration of Diclofenac Sodium Sustained-release Tablets. The knee functions of the patients were assessed by Western Ontario and McMaster Universities osteoarthritis index (WOMAC) before and after the treatment. The clinical effects were observed in the two groups after four-week continuous treatment.

Results:The total effective rate was 86.7% in the HCPM group and 73.3% in the WM group. The difference in the total effective rate between the two groups was statistically significant (P＜0.05). After treatment, WOMAC scores in the two groups were statistically different than those of the same group before the treatment (bothP＜0.05); the difference between the two groups were statistically significant (P＜0.05).

Conclusion:Herbal cake-partitioned moxibustion and oral administration of Diclofenac Sodium Sustained-release Tablets can improve the knee functions of KOA patients, but the therapeutic effect was better by herbal cake-partitioned moxibustion than by oral administration of Diclofenac Sodium Sustained-release Tablets.